Updated 23 October 2026
Surgical and endoscopy device distributors in Czechia: 13 licensed establishments
Czechia has 13 licensed establishments in the Index and no independent distributor yet.
The Bastion Hale Distributor Index lists 13 establishments in Czechia whose registry records include surgery and endoscopy: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 3 manufacturers' own import or sales entities, 0 regulatory representatives, and 10 manufacturers or exporters, out of 868 medical device establishments in Czechia overall. The records come from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada, last seen on 23 October 2026.
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Include manufacturers, their own sales entities and regulatory representatives (13)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 1SpofaDental a.s.Jicin0 lines3 registrationssize 40.6
- 20 lines2 registrationssize 39.4
- 3DINA - HITEX, spol. s r.o.Bučovice0 lines1 registrationsize 29.6
- 4Synthesia Nitrocellulose, a.s.Pardubice0 lines4 registrationssize 33.5
- 5Lohmann & Rauscher s.r.o.Nová Paka Jicin0 lines3 registrationssize 27.9
- 6Arrow International C.R. a.s.Hradec Kralove0 lines2 registrationssize 43.3
- 7STERIS AST CZ s.r.o.VELKA BITES Vysocina0 lines1 registrationsize 34.0
- 8NOVANTA MEDICAL S.R.O.Prelouc Pardubicky Kraj0 lines1 registrationsize 30.0
- 9Olympus Medical Products CzechPrerov II Predmosti0 lines1 registrationsize 27.0
- 10SCHOTT CR, S.R.O.Valasske Mezirici Zlinsky Kraj0 lines1 registrationsize 26.3
- 11safemed medical devices s.r.o.Prague Praha, Hlavni Mesto0 lines1 registrationsize 24.6
- 12Resorba, s.r.oDomazlice0 lines1 registrationsize 21.1
- 13CIMPAX CZ s.r.o.Vyskov0 lines1 registrationsize 18.5
General and plastic surgery covers instruments, electrosurgery, endoscopes, sutures and staplers. Most registries place surgical instruments in their largest category, so this segment usually has the most establishments and the widest spread of company sizes. Many of them are small instrument makers and importers rather than full-line distributors.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 2 | 15% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 2 | 15% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 2 | 15% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 13 | 100% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 1 | 8% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Czechia
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about surgery and endoscopy distributors in Czechia
How many surgery and endoscopy distributors are there in Czechia?
The Index counts 13 establishments in Czechia with surgery and endoscopy in their registry record, of which 0 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada and was last refreshed on 23 October 2026.
Who can hold a surgery and endoscopy device registration in Czechia?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find a surgery and endoscopy distributor in Czechia?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Czechia to see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a surgery and endoscopy distributor in Czechia?
A company that appears in a public regulatory registry with an address in Czechia and whose linked device listings fall in the surgery and endoscopy segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Czechia
Surgery and endoscopy in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 12 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 4 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 4 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 2 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.